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Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03097900
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

Postoperative ileus is a frequently occurring surgical complication. It is defined as temporary inhibition of propulsive bowel activity and is manifested by abdominal distention, nausea, vomiting and diet intolerance. It may lead to a prolonged hospital stay, hospital-acquired infections or complications that may require additional treatments (e.g. analgesia, fluids, electrolyte replacement, nasogastric tube decompression), and as a result increase medical costs.

Previous studies showed that postoperative coffee consumption shortens the time to first bowel movement after colorectal resections. However, none could explain the mechanism by which coffee stimulates intestinal motility and the determinant agent for this action is still up for discussion (either caffeine or another coffee component).

Coffee has a negligible caloric content; It has a pH that varies from 5 to 6 (less acidity than other beverages that have no similar effect on bowel motility) and it is hypotonic. Therefore, it is highly unlikely that bowel motility is due to the physical properties of the coffee. Much more likely, that one (or more) of the numerous phytochemicals of the coffee bean are responsible for this effect, when the most obvious candidate seems to be caffeine. However, as mentioned above, very little evidence exists that caffeine was responsible for the observed effect on colonic function in previous studies.

The purpose of this single-centered, prospective, single blinded, randomized clinical trial is to evaluate whether the use of caffeine in the post-operative period significantly reduces the duration of postoperative ileus, and therefore, improves recovery and shorten the hospital stay.

The study hypothesis is that post-operative use of caffeine will reduce time to recovery of GI function (post-operative ileus) by at least 15 hours and thus reduce hospital length of stay by at least 15 hours in patients undergoing elective colorectal operations.

50 patients due to undergo large bowel resection via laparotomy or laparoscopy will be enrolled and randomized (1:1) to those who will receive caffeine (100 mg 3 times per day) and those who will receive placebo (tap water) starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Drug: Caffeine Citrate Other: Water Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment (Caffeine Citrate) group
25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.
Drug: Caffeine Citrate
25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.
Other Name: Cafcit

Placebo Comparator: Placebo (Water) group
25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.
Other: Water
25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.




Primary Outcome Measures :
  1. First postoperative flatus [ Time Frame: Throughout hospital stay for a maximum of 30 days ]
    The time in hours from end of surgery to first flatus.


Secondary Outcome Measures :
  1. First bowel movement [ Time Frame: Throughout hospital stay for a maximum of 30 days ]
    The time in hours from end of surgery to first bowel movement.

  2. Tolerance of solid diet [ Time Frame: Throughout hospital stay for a maximum of 30 days ]
    The time in hours from end of surgery to first solid meal tolerated (the first time the patient is able to eat any food requiring chewing, without vomiting or going back to liquid diet)

  3. Length of postoperative hospital stay. [ Time Frame: Throughout hospital stay for a maximum of 30 days ]
    The postoperative hospital stay is the number of hours from surgery until discharge. The criteria for hospital discharge include stable vital signs with no febrile morbidity for ≥24 hours, passage of stool, toleration of a solid diet and the absence of other complications.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
  2. Males and females, 18 to 80 years of age inclusive at the time of study screening;
  3. Due to undergo large partial / total bowel resection via laparotomy or laparoscopy with primary anastomosis.

Key Exclusion Criteria

  1. Scheduled for a colon resection with stoma creation or multi-visceral resection.
  2. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
  3. American Society of Anesthesiologists (ASA) Class IV or V
  4. History of abdominal carcinomatosis
  5. History of radiation enteritis
  6. Children <18 or adults > 80 years of age
  7. Pregnant women
  8. Known allergy to caffeine
  9. Consumption of more than 800 milligrams of caffeine (8-10 cups of coffee) daily on a regular basis
  10. Complete abstention of caffeine consumption on a regular basis
  11. Consumption of drugs which are either substrates or inhibitors of CYP1A2 enzyme (Ciprofloxacin, Fluvoxamine or Clozapine( at the time of the study, due to expected change of caffeine metabolism it these patients
  12. Postoperative ventilation, pressor requirement or ICU stay
  13. Liver failure or/and liver cirrhosis (MELD>15)
  14. Urgent surgery e.g. emergent laparotomy, sepsis, diverting stoma.
  15. Opioid treatment for at least a week before surgery.
  16. Prior extensive abdominal surgery (not including caesarean section, appendectomy, cholecystectomy or hernia repair).
  17. Known impaired mental status or language difficulties.
  18. Participation in another interventional trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097900


Locations
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Israel
Hadassah Medical Organization
Jerusalem Region, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Noam Shussman, MD Hadassah Medical Organization
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03097900    
Other Study ID Numbers: CAFFEINE-HMO-CTIL
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hadassah Medical Organization:
Postoperative Ileus
Caffeine Citrate
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Caffeine
Caffeine citrate
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents